At least 14 countries have reported the detection of falsified Ozempic, a World Health Organization representative said, as demand for the popular diabetes and weight loss drug continues to surge worldwide.
About 10 days ago, the UN health agency had issued a medical alert on falsified batches of semaglutide (the ingredient used in Ozempic) – following confirmed reports from three countries – Brazil, the United Kingdom and the United States.
Responding to queries from businessline on similar reporting and possible source of these falsified medicines, a WHO spokesperson said, “the World Health Organization (WHO) has been actively monitoring and responding to reports of falsified OZEMPIC (semaglutide) since September 2022. WHO has received reports of falsified OZEMPIC detected in at least 14 countries across 4 different WHO regions.”
While confirmed reports are from the three countries mentioned in the medical alert “Details from the other countries cannot be shared at the moment as information is undergoing validation,” the spokesperson added.
On whether Ozempic was the only product hit by these falsified versions, the spokesperson said, “We do not have any other brand of GLP-1 product recorded in our Global Surveillance and Monitoring System (GSMS) as falsified.”
The oral pill version of semaglutide, from Novo Nordisk, is available in India.
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Most semaglutide products are injected under the skin on a weekly basis, but tablet-versions taken daily, are also available, the WHO said. Semaglutides are, however, not part of WHO-recommended treatments for diabetes management due to their current high cost, the agency said.
Ongoing investigations
On the possible source of these falsified products, the WHO spokesperson said, “National Regulatory Authorities in the impacted countries as well as the genuine product manufacturer have been investigating the source and illicit distribution of these products.” The UN health agency added that it had no further information on the details of specific investigations, including information on the source of these falsified products.
The falsified batches listed in the medical product alert “were not reported to WHO as being sourced from the internet. However, patients should avoid buying medicines from unauthorized sources including websites not licensed or authorized to sell medical products,” the representative said.
Late last year, the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA) had cautioned patients and healthcare professionals on falsified and counterfeit semaglutide, respectively, in their regions. Patients were urged to buy their supplies from authentic retailers, while doctors expressed concern on possible online sales.
Global red-flags
In October 2023, the EMA had said, it had been notified by competent authorities that pre-filled pens falsely labelled as Ozempic had been identified at wholesalers in the European Union and the UK.
“The pens, with labels in German, originated from wholesalers in Austria and Germany,” the EMA said. “The pens have batch numbers, 2D barcodes and unique serial numbers from genuine Ozempic packs. In the EU, each medicine pack has a unique 2D barcode and serial number so that it can be tracked in an EU-wide electronic system.”
“When the packs of the falsified Ozempic were scanned, the serial numbers were shown to be inactive, thereby alerting operators to a potential falsification, the EMA explained, adding that the European and German regulatory authorities had issued statements of non-compliance with good distribution practices to the concerned wholesalers in their countries for not following required procedures.”
“In December 2023, the FDA said it was investigating “counterfeit Ozempic (semaglutide) injection 1 milligram (mg) in the legitimate US drug supply chain and has seized thousands of units of the product.”
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